BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1904580 · Received November 22, 2010

    Report

    Report Number
    2954323-2010-01587
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 22, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED CUSTOMER WAS GETTING AN ERR-6 MESSAGE ON THEIR PXTRA METER AND EXPERIENCED SEIZURE BECAUSE HER BLOOD GLUCOSE WAS HIGH. THE CALLER FURTHER STATED THE PARAMEDICS WERE CALLED, TREATED CUSTOMER WITH INSULIN AND TRANSPORTED HER TO A HEALTH CARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA, HOWEVER THE CALLER DENIED ANY TREATMENT PROVIDED AT THE HOSPITAL. THE CALLER ALSO REPORTED THAT THE DOCTOR STATED THAT HER BLOOD SUGAR WAS 450MG/DL. THE SOURCE OF THE READING IS UNKNOWN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R